BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2083732 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01358
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    November 15, 2010
    Report Date
    April 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. QC, CALIBRATION, AND SYSTEM CHECK DATA WERE NOT SUPPLIED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. CUSTOMER SUSPECTED SAMPLE HANDLING, ESPECIALLY SPINNING, AS THE CAUSE OF THE ERRONEOUS RESULT.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER INC. (BCI) REGARDING THE TROPONIN (ACCUTNI) ASSAY PERFORMANCE, THE CUSTOMER STATED THAT THEIR LABORATORY HAD OBTAINED FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER, FOR ONE (1) PATIENT. THE FALSE RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER REPORTED THAT THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1